Evaluating Combination Therapy Using Autologous Dendritic Cells Pulsed With Antigen Peptides and Nivolumab for Subjects With Advanced Non-Small Cell Lung Cancer

Evaluating Combination Therapy Using Autologous Dendritic Cells Pulsed With Antigen Peptides and Nivolumab for Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC)

Study Arms: Patients receive autologous dendritic cells pulsed with antigen peptides ID on days 15, 29, 43,57,71,99,127and 155, and nivolumab IV over 60 minutes on days 15, 29, 43,57,71,85 99 and 113.

Study Overview

• Status: Unknown
• Conditions: NSCLC
• Intervention / Treatment: Drug: Autologous dendritic cells pulsed with antigen

Detailed Description

Immune checkpoint inhibitors are increasingly drawing much attention in the therapeutic development for cancer treatment. However, many cancer patients do not respond to treatments with immune checkpoint inhibitors, partly because of the lack of tumor-infiltrating effector T cells. DC vaccine may prime patients for treatments with immune checkpoint inhibitors by inducing effector T-cell infiltration into the tumors and immune checkpoint signals. The combination of DC vaccine and an immune checkpoint inhibitor may function synergistically to induce more effective antitumor immune responses, and clinical trials to test the combination are currently needed.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Recruiting
      • Henan Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Be 20 years of age or older on day of signing informed consent.
2. Non-small cell lung cancer (NSCLC) patient with progression on or after platinum-based chemotherapy.
3. Have measurable disease based on Response Evaluation in Solid Tumors (RECIST) 1.1.
4. Have a performance status of 0 - 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
5. Life expectancy of >6 months.
6. Females of childbearing potential should have a negative urine or serum pregnancy.
7. Serum glutamate pyruvate transaminase (SGPT) =< 4.0 times upper limits of normal (ULN)
8. Serum glutamic-oxaloacetic transaminase (SGOT) =< 4.0 times ULN
9. Creatinine =< 2 times ULN
10. Patients who have one of the following HLA types: A2402, A0201, A0206
11. Pre-Leukaphersis evaluation
12. Hemoglobin > 10 g/dL (100 g/L)
13. White blood cell count 3.0-11.0 x 10^3/mm^3 (3.0-11.0 x 10^9/L)
14. Absolute granulocyte count >= 1.5 x 10^3/mm^3 (1.5 x 10^9/L)
15. Absolute lymphocyte count >= 1.0 x 10^3/mm^3 (1.0 x 10^9/L)
16. Platelet count >= 100 x 10^3/mm^3 (100 x 10^9/L)

Exclusion Criteria:

1. Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
2. Has a diagnosis of immunodeficiency or is receiving systemic steroid or any other form of immunosuppressive therapy.
3. Hypersensitivity to nivolumab or any of its excipients.
4. Has a known additional malignancy.
5. Any diagnosis of autoimmune disease.
6. Pregnant or breastfeeding within the projected duration of the trial, starting with screening visit through the last dose of trial treatment.
7. Positive HIV-1, -2, or HTLV-1, -2, tests.
8. Positive HBV or HCV tests.
9. Positive syphilis tests.
10. Recipient of organ allografts.
11. Inability or unwillingness to return for required visits and follow-up exams.
12. Acute infection: any active viral, bacterial, or fungal infection that requires specific therapy.
13. Active uncontrolled infection, such as a sexually transmitted disease (STD), herpes, uncontrolled tuberculosis, malaria, etc.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Autologous dendritic cells pulsed with antigen; peptide(WT1-H/K-HELP, Survivin-H/K-HELP,MAGE-A4-H ⁄ K-HELP and MUC1-22) . Each dose contains of 10 million activated autologous DCs. Route of Administration: Intradermal.	Drug: Autologous dendritic cells pulsed with antigen; peptide(WT1-H/K-HELP, Survivin-H/K-HELP,MAGE-A4-H ⁄ K-HELP and MUC1-22) . Each dose contains of 10 million activated autologous DCs. Route of Administration: Intradermal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS)	From date of randomization until the date of first documented progression or date of death from any cause	up to 2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival(OS)	From date of randomization until the date of death from any cause	up to 2 year
Objective response rate (ORR)	From date of randomization until the date of death from any cause	up to 1 year
Disease Control Rate (DCR)	Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.	up to 1 year

Collaborators and Investigators

• Sponsor: Henan Cancer Hospital
• Collaborators: Cttq

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2019
• Primary Completion (ANTICIPATED): January 1, 2021
• Study Completion (ANTICIPATED): January 1, 2022

Study Registration Dates

• First Submitted: December 12, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (ACTUAL): December 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 16, 2019
• Last Update Submitted That Met QC Criteria: December 12, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 2019111810

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No